Acute Coronary SyndromePhase 4NCT01826175
Comparison of Ticagrelor Versus Clopidogrel on Residual Thrombus Burden During PCI: an OCT Study
A Phase 4 study testing Ticagrelor, Clopidogrel and Optical Coherence Tomography in people with Acute Coronary Syndrome and Coronary Artery Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Subjects with acute coronary syndromes scheduled for cardiac catheterization will be enrolled in this study. Subjects that are to be treated clinically with coronary artery stenting will be randomized to receive a loading dose of clopidogrel versus ticagrelor after diagnostic angiography but prior to stenting. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Acute Coronary Syndrome, Coronary Artery Disease
- What is being tested?
- Ticagrelor, Clopidogrel and Optical Coherence Tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient Characteristics:
- Males and non-pregnant females > 18 and < 79 years of age presenting with acute coronary syndrome defined as having two of the following criteria:
- Signs and symptoms consistent with accelerated angina or prolonged angina (lasting greater than 20 minutes) either at rest or with minimal exertion
- ECG changes indicative of new ischemia
- Levels of cardiac biomarkers (troponin-T) above the upper limit of the normal range.
- Patients scheduled to undergo coronary angiography with possible percutaneous coronary intervention (PCI)
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- Lesion Characteristics on Diagnostic Coronary Angiography
- De novo lesions in native coronary arteries found by diagnostic coronary angiography
- Angiographic stenosis <100%
- Reference vessel diameter 2.5 mm - 4.0 mm by visual estimation
Who cannot join
- General Exclusion Criteria
- Subjects who are unable or unwilling to sign the informed consent form
- Subjects being treated with anti-platelet medications other than aspirin prior to diagnostic catheterization including glycoprotein IIb/IIIa inhibitors.
- Subjects with serious co-morbid conditions that in judgment of the investigator preclude inclusion in this study
- Subjects with NYHA class III or IV heart failure or known left ventricular ejection fraction < 30%
- Subjects with an ST elevation myocardial infarction
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- Subjects with hemodynamic or electrical instability (including shock)
- Subjects diagnosed with severe, non-catheter-related coronary artery spasm
- Subjects who are or may be pregnant
- Subjects with known allergies to contrast media
- Subjects with renal failure as defined by eGFR < 60.
- History of TIA or stroke < 6 months
- History of hemorrhagic stroke
- Hepatic insufficiency defined as liver cirrhosis, AST/ALT/Alkaline Phosphatase greater than 3 times the upper limit of normal or hyperbilirubinemia.
- Lesion Specific Exclusion Criteria These exclusion criteria apply to the target lesion to be imaged by OCT.
- Lesion located in the left main coronary artery
- Lesions that are heavily calcified
- Lesions where OCT cannot be performed due to technical difficulties
- Other lesions that the investigator deems inappropriate for the procedure such as sites with excessive tortuosity or low flow by TIMI grade.
- Lesion in saphenous vein or arterial conduit
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Comparison of Ticagrelor Versus Clopidogrel on Residual Thrombus Burden During Percutaneous Coronary Intervention: an Optical Coherence Tomography Study
Subjects with acute coronary syndromes scheduled for cardiac catheterization will be enrolled in this study. Subjects that are to be treated clinically with coronary artery stenting will be randomized to receive a loading dose of clopidogrel versus ticagrelor after diagnostic angiography but prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and the presence of blood clots inside the new stent will be measured and compared between the groups.
Read the detailed description
Subjects with acute coronary syndromes scheduled for cardiac catheterization will be enrolled in this study. Subjects that are to be treated clinically with coronary artery stenting will be randomized to receive a loading dose of clopidogrel versus ticagrelor after diagnostic angiography but prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and the presence of blood clots inside the new stent will be measured and compared between the groups
- Conditions
- Acute Coronary Syndrome, Coronary Artery Disease
- Being tested
- Ticagrelor, Clopidogrel, Optical Coherence Tomography
- Keywords
- Optical Coherence Tomography, ticagrelor, clopidogrel
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Brilinta, Brilique, Possia
Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
ClopidogrelDrug
Also called Plavix
Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
Optical Coherence TomographyDevice
Also called OCT
Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Experimental | Subjects receive 180 mg of ticagrelor immediately prior to coronary artery stenting and have optical coherence tomography imaging after the stenting procedure. Receives: Drug: Ticagrelor; Device: Optical Coherence Tomography |
| Clopidogrel | Active comparator | Subjects receive 600 mg of clopidogrel immediately prior to coronary artery stenting and have optical coherence tomography imaging after the stenting procedure. Receives: Drug: Clopidogrel; Device: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total thrombus burden as measured by the volume of in-stent thrombus quantified by planimetry.
The total thrombus burden measured on OCT images will be assessed. The volume of in-stent thrombus will be quantified by planimetry.
Measured: Thrombus burden will be measured at the end of the coronary artery stenting procedure.
Secondary outcomes (2)
PRI (platelet reactivity index) as measured by the PLT-VASP assay.
The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays.
Measured: PRI will be measured at the time of OCT image acquistion (which will occur at the end of the coronary artery stenting procedure).
P2Y12 Reaction Units as measured by the VerifyNow P2Y12 assay.
The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays.
Measured: P2Y12 will be measured at the time of OCT image acquistion (which will occur at the end of the coronary artery stenting procedure).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Study terminated mutually by sponsor \& PI due to no enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
- Investigators
- Ik-Kyung Jang, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826175
- Sponsor's protocol ID
- 2013P000225
- Status last verified
- Dec 2016
- First submitted
- 1 Apr 2013
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ticagrelor Versus Clopidogrel on Residual Thrombus Burden During Percutaneous Coronary Intervention: an Optical Coherence Tomography Study
- ClinicalTrials.gov ID
- NCT01826175
- Acronym / sponsor ID
- 2013P000225
- Conditions
- Acute Coronary Syndrome, Coronary Artery Disease
- Keywords
- Optical Coherence Tomography, ticagrelor, clopidogrel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated mutually by sponsor \& PI due to no enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 8 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects with acute coronary syndromes scheduled for cardiac catheterization will be enrolled in this study. Subjects that are to be treated clinically with coronary artery stenting will be randomized to receive a loading dose of clopidogrel versus ticagrelor after diagnostic angiography but prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and the presence of blood clots inside the new stent will be measured and compared between the groups.
Detailed description
Subjects with acute coronary syndromes scheduled for cardiac catheterization will be enrolled in this study. Subjects that are to be treated clinically with coronary artery stenting will be randomized to receive a loading dose of clopidogrel versus ticagrelor after diagnostic angiography but prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and the presence of blood clots inside the new stent will be measured and compared between the groups
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Experimental | Drug: Ticagrelor, Device: Optical Coherence TomographySubjects receive 180 mg of ticagrelor immediately prior to coronary artery stenting and have optical coherence tomography imaging after the stenting procedure. |
| Clopidogrel | Active comparator | Drug: Clopidogrel, Device: Optical Coherence TomographySubjects receive 600 mg of clopidogrel immediately prior to coronary artery stenting and have optical coherence tomography imaging after the stenting procedure. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and non-pregnant females > 18 and < 79 years of age presenting with acute coronary syndrome defined as having two of the following criteria:
- Patients scheduled to undergo coronary angiography with possible percutaneous coronary intervention (PCI)
- Lesion Characteristics on Diagnostic Coronary Angiography
- De novo lesions in native coronary arteries found by diagnostic coronary angiography
- Angiographic stenosis <100%
Key exclusion criteria (20 listed)
- General Exclusion Criteria
- Subjects who are unable or unwilling to sign the informed consent form
- Subjects being treated with anti-platelet medications other than aspirin prior to diagnostic catheterization including glycoprotein IIb/IIIa inhibitors.
- Subjects with serious co-morbid conditions that in judgment of the investigator preclude inclusion in this study
- Subjects with NYHA class III or IV heart failure or known left ventricular ejection fraction < 30%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TicagrelorAlso: Brilinta, Brilique, PossiaSubjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures. | Drug | Ticagrelor |
| ClopidogrelAlso: PlavixSubjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures. | Drug | Clopidogrel |
| Optical Coherence TomographyAlso: OCTSubjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures. | Device | Clopidogrel, Ticagrelor |
Primary outcome
Total thrombus burden as measured by the volume of in-stent thrombus quantified by planimetry.
Time frame: Thrombus burden will be measured at the end of the coronary artery stenting procedure.
The total thrombus burden measured on OCT images will be assessed. The volume of in-stent thrombus will be quantified by planimetry.
2 secondary outcomes
PRI (platelet reactivity index) as measured by the PLT-VASP assay.
Time frame: PRI will be measured at the time of OCT image acquistion (which will occur at the end of the coronary artery stenting procedure).
P2Y12 Reaction Units as measured by the VerifyNow P2Y12 assay.
Time frame: P2Y12 will be measured at the time of OCT image acquistion (which will occur at the end of the coronary artery stenting procedure).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ik-Kyung Jang, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ticagrelor, Clopidogrel and Optical Coherence Tomography in people with Acute Coronary Syndrome and Coronary Artery Disease, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total thrombus burden as measured by the volume of in-stent thrombus quantified by planimetry. (time frame: Thrombus burden will be measured at the end of the coronary artery stenting procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2016.